Past Events

Draft Petition Urges FDA to Require Botulism Testing for Powdered Infant Formula and Its Dairy Ingredients

The agency sent a letter to formula makers on July 13 urging vigilance in choosing ingredients, has asked international expert bodies to assess spore-forming pathogens in infant formula, and is reviewing a September report from a Reagan-Udall Foundation roundtable on formula safety.

FDA and EMA Discuss Collaboration on Herbal / Botanical Drug Products

To address those gaps, we have started engagement with the botanical community by holding a roundtable with the Reagan-Udall Foundation for the FDA to start the dialogue with key stakeholders to better understand the barriers they see.

FDA wants feedback on new Rare Disease Framework Initiative

The meeting on October 28 runs from 1:00 to 5:00 p.m. ET, in person at White Oak, or online, with registration through the Reagan-Udall Foundation.

FDA's Generics Chief Steps Down Citing Political Pressure, And The Agency's Rare Disease Plan Faces Its First Test

Sutter noted that repurposing has become an administration priority, citing recent work on a Leucovorin labeling change and a Reagan-Udall Foundation meeting on repurposing.

US FDA Launches Rare Disease Drug Development Initiative

To solicit feedback on the Rare Disease Framework Initiative from patients and disease advocates, industry, and others, the FDA will host a meeting at the FDA’s White Oak campus. The meeting will be facilitated by the Reagan-Udall Foundation for the FDA.

FDA Seeks Feedback on Rare Disease Drug Development

The agency further announced a “Fit-for-Purpose Rare Disease Framework Initiative” public meeting being convened in collaboration with the Reagan-Udall Foundation on October 28, 2026.

OrphanPulse Wk 42: Europe Backed Ascendis’ Weekly Achondroplasia Shot Ahead of the First Pill

FDA holds a public meeting at White Oak on 28 October, facilitated by the Reagan-Udall Foundation, and Medical Daily reports comments are open through 11 December. FDA says only about 5% of rare conditions have an approved treatment.

The Food Traceability Rule Has Been Law Since 2022. Nobody Has to Follow It Until July 2028. Here Is How That Happened, and What FDA Is Doing with the Time

The 2024 Reagan-Udall Foundation roundtables found low awareness of the rule among small and foreign suppliers and nonchain restaurants, and distributors have real problems with mixed-lot pallets and pick slots.

FDA Launches Rare Disease Framework Initiative to Modernize Small-Cohort Trial Design

To begin shaping the detailed regulations, revised guidances, and internal reviewer training modules, the FDA will convene a major public stakeholder summit on October 28 at its White Oak headquarters in Silver Spring, Maryland, facilitated by the Reagan-Udall Foundation.

Special Seminar: An Interactive Session Offering Expert Insight on Engaging Potential Research Support

As an appointee to the board of the FDA’s Reagan-Udall Foundation, Ed joins a high-profile list of life sciences leaders including former FDA Commissioners, global biotech executives and CMS health policy administrators.